NCT01649557

Multicenter, Open-label, Safety and Tolerability Study

A Phase 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Monotherapy in Adult Patients With Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 67 Years
• Healthy volunteers: Not accepted

Summary

This will be a multicenter, 52 week, open label study to assess the safety and tolerability of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study will be conducted on an outpatient basis. Enrollment into the study will be drawn from eligible subjects who have completed participation in Study 331-07- 203 and who, in the investigator's judgment, would benefit from continued treatment with oral OPC-34712.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	OPC-34712	oral administered once daily

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-08-01
• Completion: 2011-09-01
• First posted: 2012-07-25
• Last updated: 2015-10-29
• Results posted: 2015-10-29

Locations

68 sites across 12 countries: United States, Bulgaria, Croatia, India, Philippines, Romania, Russia, Serbia, Slovakia, South Korea, Taiwan, Ukraine